Identifying treatable features of severe asthma to create personalized treatment plans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter effort enrolls adults with severe, uncontrolled asthma at tertiary hospitals and performs a comprehensive, multidisciplinary evaluation including lung function tests, fractional exhaled nitric oxide (FeNO), blood routine, allergen IgE, chest CT, and detailed questionnaires. Investigators will map the distribution of potentially modifiable traits and assign individualized cluster management compared with routine asthma treatment. Outcomes such as asthma control and quality of life will be followed over six months to see how trait-guided bundles affect symptoms and exacerbations. The project aims to link specific treatable characteristics to patient-centered outcomes to inform personalized care pathways.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years, and \<80 years with a definite diagnosis of asthma for at least 6 months
* Patients met the 2024 GINA criteria for severe asthma, which was defined as "uncontrolled" asthma (frequent asthma symptoms, or frequent acute exacerbations) despite high-dose inhaled corticosteroids (ICS) plus long-acting β2-receptor antagonists (LABAs), or worsening of symptoms after slight tapering of high-dose therapy.
* They were willing to accept multi-disciplinary and multi-dimensional evaluation and signed informed consent
* Informed consent was obtained and patients were able to participate in the study and 6-month follow-up according to the protocol

Exclusion Criteria:

* The presence of numerous other lung tissue destructive diseases, such as severe bronchiectasis or pulmonary tuberculosis.
* Chest surgery or abdominal surgery in the past 3 months
* Eye surgery had been performed within the past 3 months
* Myocardial infarction within the previous 3 months
* Anti-tuberculosis treatment is ongoing
* Women who are pregnant and lactating
* Macrolide use within 4 weeks before the screening period
* Treatment with anti-ige, anti-IL-5, or anti-IL-5R within 4 weeks before the screening period
* Inhaled ICS+LABA+ long-acting anticholinergic agent (LAMA) for 4 weeks prior to the screening period 4. Allergy to macrolides
* QTc interval prolongation \>480ms
* Taking medications that interact with azithromycin, causing QTc prolongation or existing ECG abnormalities, may lead to arrhythmia

Where it's running

• Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Beijing Tiantan Hospital Affiliated to Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• Henan Provincial People's Hospital
  Zhengzhou, Henan, China Recruiting
• The Second Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Kewu Huang, professor
• Email: kewuhuang@126.com
• Phone: 8613601234681

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.